Recruiting

Observational Study

Sponsor:

Duke University

Code:

NCT05055830

Conditions

Cardiac Disease

Critically Ill

Children, Adult

Eligibility Criteria

Sex: All

Age: 0 - 20

Healthy Volunteers: Not accepted

Interventions

The OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care.

Study Details

Brief summary:

OPTIC is a prospective, open-label, non-randomized study of multiple medications administered to approximately 2000 children in the pediatric cardiac intensive care unit (PCICU) per routine clinical car by their treating provider. The purpose of this study is to characterize the PK of drugs routinely administered to children per standard of care using opportunistic and scavenged samples. The prescribing of drugs to children will not be part of this protocol.

After the child/adult (<21 years of age) is consented/enrolled, demographic and clinical data will be extracted from the EHR. Biospecimen information (including date and time of sample collection) will be collected.

Data analysis will be conducted on all participants with at least 2 evaluable samples. The protocol represents minimal risk to the children/adults who provide body fluid for this study, including potential loss of confidentiality (samples will be assigned a unique accession number) and risks associated with blood draws. Adverse Events (AEs)/Serious Adverse Events (SAEs) caused by the study specimen collections will be monitored and recorded in the Electronic Data Capture (EDC) system.

Conditions

Cardiac Disease

Critically Ill

Children, Adult

Study ID

NCT05055830

Start date

Oct 5, 2021

Status verified date

Nov, 2025

Completion date

Oct 30, 2028

Anticipated

Primary completion date

Oct 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 20

Healthy Volunteers: Not accepted

Inclusion Criteria:

To be eligible for enrollment, a potential participant must meet all the following criteria:

1. Participant is <21 years old on admission
2. Participant is admitted to the Pediatric Cardiac Intensive Care Unit
3. Parent/legal guardian/adult participant can understand the consent process and is willing to provide informed consent/assent
4. Participant is receiving one or more of the study drugs of interest at the time of enrollment

Exclusion Criteria:

1\. Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

Children (<21 years of age) who are prescribed drugs of interest

Children and young adults who are prescribed drugs of interest as part of their routine medical care and are admitted to the pediatric cardiac intensive care unit

Interventions

The OPTIC study is collecting PK data on children prescribed understudied drugs of interest per standard of care.

The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws), this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care.

Primary outcome measure

  • Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling [ Time Frame: Data will be collected up to 180 days from the time of consent ]
  • Half-life (t1/2) as measured by PK sampling [ Time Frame: Data will be collected up to 180 days from the time of consent ]
  • Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling [ Time Frame: Data will be collected up to 180 days from the time of consent ]
  • AUC (area under the curve) as measured by PK sampling [ Time Frame: Data will be collected up to 180 days from the time of consent ]

Central Contacts and Locations

Central contacts

Stefany Olague, MPH

9196688131smalltrials-CRC@duke.edu

Locations

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27705

More Information

Sponsor

Duke University

Last update posted

Nov 14, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2025-11-14.